The goal of this study is to determine if biomarkers can be used to be predictive of renal disease progression in diabetes as a method to enrich clinical trials with patients most at risk. From the SUMMIT (Surrogate Markers for Micro- and Macrovascular Hard Endpoints for Innovative Diabetes Tools) programme, the authors originally identified 207 serum biomarkers that is predictive of renal function decline. From these 207 biomarkers, the authors selected 42 biomarkers using forward selection and least absolute shrinkage and selection operator (LASSO) penalized regression approaches. The 42 biomarkers were split into smaller panels and tested for the ability to predict performance similar to the larger panels.
This study suggests five urinary biomarkers can be useful in in diagnosing infertility in men. The potential biomarkers from this study are expected to help researchers develop a test that screens for normozoospermic infertility, a condition that existing tests typically do not defect.
Nephrotoxicity is a major problem in the preclinical and clinical setting that results in the failure of candidate compounds throughout the drug-development cycle. An article in this month’s GEN outlines the development of a new generation of biomarkers for drug-induced toxicity that provides greater sensitivity and earlier detection than previous methods.
A clinical test measuring tissue inhibitor of metalloproteinases (TIMP)-2 and insulin-like growth factor binding protein 7 (IGFBP7) in urine has been validated to identify patients at risk for impending AKI.
The authors of this paper review the various methods of safety biomarker discovery and development, and challenge researchers to advance the use of safety biomarkers that are indicative of drug-induced toxicity. This type of research typically spans both preclinical and clinical development programs. Having the ability to identify translational safety biomarkers on the same technology platform is one of Myriad RBM’s strengths.
Researchers identified a 3-biomarker immunoassay, measuring NNMT, LCP1, and NM23A, that successfully distinguishes healthy patients from those with renal cell carcinoma (RCC). If their results can be validated, physicians would have an unprecedented tool for the early detection and subsequent treatment of this silent and deadly disease.
Researchers at the University of Cincinnati College of Medicine, Ohio State University, and Johns Hopkins have identified several biomarkers of early kidney damage in patients suffering from lupus. Various combinations of the markers, including neutrophil gelatinase-associated lipocalin (NGAL) and monocyte chemotactic protein 1 (MCP-1), along with more traditional kidney markers, were able to accurately predict renal biopsy scores and disease outcome. Using these markers to measure clinical endpoints offers hope for noninvasive methods of monitoring the progression of lupus nephritis.